At a glance
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NCT06440057Phase 2RecruitingMonitorUpdated 18mo ago · Completion was 2mo agoA Phase I Dose Escalation Study of Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by a Phase II Dose Expansion Study in Participants With Neuroendocrine Carcinoma.
In Brief
A Phase 2 clinical trial evaluating ZG006 for Neuroendocrine Carcinoma. Currently recruiting, targeting 78 participants across 1 site.
Signals
Detailed Summary
This is a multicenter, open-label phase I/II study, divided into 2 parts: Part 1 involves a dose-escalation study of ZG006 in which the safety and tolerability of ZG006 in patients with advanced small cell lung cancer or neuroendocrine carcinoma are explored. Upon completion of Part 1, investigators and the sponsor will discuss and determine two recommended phase II doses (RP2D) based on safety, preliminary efficacy, and pharmacokinetic results for use in Part 2. Part 2 is a phase II dose-expansion study of ZG006, aiming to investigate the efficacy and safety of ZG006 in patients with Neuroendocrine Carcinoma.
Study Details
Timeline
Interventions
ZG006 will be administered as an intravenous (IV) infusion.